DDH AUC Specialists

143 Pages·2017·2.22 MB·English

by  Jayson Murray

Appropriate Use Criteria for the Management of
Developmental Dysplasia of the Hip in Infants up to Six
Months of Age

Intended for Use by Orthopaedic Specialists

Adopted by the American Academy of Orthopaedic Surgeons
Board of Directors
March 5, 2018

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AAOS Evidence-Based Medicine Unit
www.orthoguidelines.org/auc or download the OrthoGuidelines app via Apple or Google Play stores
Disclaimer
Volunteer physicians from multiple medical specialties created and categorized these
Appropriate Use Criteria. These Appropriate Use Criteria are not intended to be comprehensive
or a fixed protocol, as some patients may require more or less treatment or different means of
diagnosis. These Appropriate Use Criteria represent patients and situations that clinicians
treating or diagnosing musculoskeletal conditions are most likely to encounter. The clinician’s
independent medical judgment, given the individual patient’s clinical circumstances, should
always determine patient care and treatment.
Disclosure Requirement
In accordance with American Academy of Orthopaedic Surgeons policy, all individuals whose
names appear as authors or contributors to this document filed a disclosure statement as part of
the submission process. All authors provided full disclosure of potential conflicts of interest prior
to participation in the development of these Appropriate Use Criteria. Disclosure information for
all panel members can be found in Appendix B.
Funding Source
The American Academy of Orthopaedic Surgeons exclusively funded development of these
Appropriate Use Criteria. The American Academy of Orthopaedic Surgeons received no funding
from outside commercial sources to support the development of these Appropriate Use Criteria.
FDA Clearance
Some drugs or medical devices referenced or described in this document may not have been
cleared by the Food and Drug Administration (FDA) or may have been cleared for a specific use
only. The FDA has stated that it is the responsibility of the physician to determine the FDA
clearance status of each drug or device he or she wishes to use in clinical practice.
Copyright
All rights reserved. Reproduction, storage in a retrieval system, or transmission, in any form, or
by any means, electronic, mechanical, photocopying, recording, or otherwise, of any part of this
document, requires prior written permission from the American Academy of Orthopaedic
Surgeons.
Published 2018 by the American Academy of Orthopaedic Surgeons
9400 West Higgins Road
Rosemont, IL 60018
First Edition
Copyright 2018 by the American Academy of Orthopaedic Surgeons

2
AAOS Evidence-Based Medicine Unit
www.orthoguidelines.org/auc or download the OrthoGuidelines app via Apple or Google Play stores
For a more user-friendly version of this AUC, or to view additional
AUCs, please visit the AAOS AUC web-based app at:

www.OrthoGuidelines.org/auc

To view the clinical practice guideline for this topic, please visit

http://www.orthoguidelines.org/topic?id=1016
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AAOS Evidence-Based Medicine Unit
www.orthoguidelines.org/auc or download the OrthoGuidelines app via Apple or Google Play stores
Table of Contents
Writing Panel .............................................................................................................................. 4
Voting Panel................................................................................................................................ 6
Voting Panel Round Two Discussion Moderator ....................................................................... 7
AUC Section Leader, AAOS Committee on Evidence-Based Quality and Value ..................... 7
Chair, AAOS Committee on Evidence-Based Quality and Value .............................................. 7
Chair, AAOS Council on Research and Quality ......................................................................... 7
AAOS Staff ................................................................................................................................. 7
I. INTRODUCTION ...................................................................................................................8
Overview ..................................................................................................................................... 8
INTERPRETING THE APPROPRIATENESS RATINGS ....................................................... 9
Burden of Disease ....................................................................................................................... 9
Natural History.......................................................................................................................... 10
Etiology ..................................................................................................................................... 10
Risk factors ............................................................................................................................... 11
Potential Benefits, Harms, And Contraindications ................................................................... 11
II. METHODS ............................................................................................................................12
Developing Criteria ................................................................................................................... 13
Formulating Indications and Scenarios ..................................................................................... 13
Figure 1. Developing Criteria ............................................................................................... 14
Creating Definitions and Assumptions ..................................................................................... 14
Literature Review...................................................................................................................... 15
VOTING PANEL MODIFICATIONS TO WRITING PANEL MATERIALS ...................... 16
Determining Appropriateness ................................................................................................... 17
Voting Panel.......................................................................................................................... 17
Rating Appropriateness ......................................................................................................... 17
Round One Voting ................................................................................................................ 18
Round Two Voting ............................................................................................................... 18
Final Ratings ......................................................................................................................... 18
Figure 4. Interpreting Final Ratings of Criteria .................................................................... 19
Revision Plans ........................................................................................................................... 20
Disseminating Appropriate Use Criteria ................................................................................... 21
III. PATIENT INDICATIONS AND TREATMENTS ...............................................................22
Assumptions .............................................................................................................................. 22
Patient Indications ..................................................................................................................... 22
IV. RESULTS OF APPROPRIATENESS RATINGS ................................................................24
Figure 6. Breakdown of Appropriateness Ratings ................................................................ 25
Figure 7. Breakdown of Agreement amongst Voting Panel ................................................. 26
Figure 8. Distribution of Appropriateness Ratings on 9-Point Rating Scale ........................ 27
Appropriate Use Criteria for The Detection and Nonoperative Management of Pediatric
Developmental Dysplasia of the Hip in Infants up to Six Months of Age ............................... 29
V. APPENDICES .....................................................................................................................141
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AAOS Evidence-Based Medicine Unit
www.orthoguidelines.org/auc or download the OrthoGuidelines app via Apple or Google Play stores
Appendix A. Documentation of Approval .............................................................................. 141
Appendix B. Disclosure Information ...................................................................................... 139
DDH writing panel member disclosures ................................................................................. 139
DDH voting panel member disclosures .................................................................................. 140
Appendix C. References ......................................................................................................... 143

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AAOS Evidence-Based Medicine Unit
www.orthoguidelines.org/auc or download the OrthoGuidelines app via Apple or Google Play stores
Writing Panel

1. Pablo Castaneda, MD 9. Kishore Mulpuri, MD
Pediatric Orthopaedic Society of North America American Academy of Orthopaedic Surgeons

2. Brian Shaw, MD 10. Cynthia N. Baker, MD, FAAP
Pediatric Orthopaedic Society of North America American Academy of Pediatrics

3. Eduardo Novais, MD 11. Joseph A. Janicki, MD, MS, FAAP
American Academy of Orthopaedic Surgeons American Academy of Pediatrics

4. Ted Whitten, BA, RDMS, RVT, FSDMS 12. John P. Lubicky, MD, FAAP
Society of Diagnostic Medical Sonography American Academy of Pediatrics

5. Hamad Ghazle, EDD, RDMS 13. Harriet Paltiel, MD, FAIUM
Society of Diagnostic Medical Sonography American Institute of Ultrasound in Medicine

6. Sarah Bixby, MD 14. Lynn Fordham, MD, FACR, FAIUM
Society for Pediatric Radiology American Institute of Ultrasound in Medicine

7. Jie Chen Nguyen, MD, MS 15. Boaz Karmazyn, MD
Society for Pediatric Radiology American College of Radiology

8. Amisha J Shah, MD 16. Sarah Milla, MD
Society for Pediatric Radiology American College of Radiology

17. Shannon Dowler, MD, FAAFP
American Academy of Family Physicians

Voting Panel

1. Sheryl Goss, MS, RT(R)(S), RDMS, 7. Vidyadhar Upasani, MD
RDCS, RVT, FSDMS American Academy of Orthopaedic Surgeons/
Society of Diagnostic Medical Sonography Pediatric Orthopaedic Society of North America

2. Nabile M. Safdar, MD, MPH 8. Alfred A. Mansour, III, MD
American College of Radiology American Academy of Orthopaedic Surgeons

3. Randall T. Loder, MD 9. Travis Matheney, MD
Pediatric Orthopaedic Society of North America American Academy of Orthopaedic Surgeons

4. Vineeta Swaroop, MD 10. Stephanie Holmes, MD
Pediatric Orthopaedic Society of North America American Academy of Orthopaedic Surgeons

5. Jennifer Lim-Dunham, MD 11. Keith Bachmann, MD
American Institute of Ultrasound in Medicine American Academy of Orthopaedic Surgeons

6. Lee Segal, MD, FAAP 12. Paul D. Choi, MD
American Academy of Pediatrics American Academy of Orthopaedic Surgeons

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AAOS Evidence-Based Medicine Unit
www.orthoguidelines.org/auc or download the OrthoGuidelines app via Apple or Google Play stores
Voting Panel Round Two Discussion Moderator
Julie B. Samora, MD, PhD, MPH

Chair, AAOS Committee on Evidence-Based Quality and Value
Kevin Shea, MD

Chair, AAOS Council on Research and Quality
Robert H. Quinn, MD

AAOS Staff
William O. Shaffer, MD
Medical Director

Deborah S. Cummins, PhD
Director, Department of Research and Scientific Affairs

Jayson Murray, MA
Senior Manager, Quality and Value

Ryan Pezold, MA
Manager, Quality and Value Development

Kaitlyn Sevarino, MBA
Manager, Quality and Value Implementation

Peter Shores, MPH
Statistician, Evidence-Based Medicine

Anne Woznica, MLS
Medical Librarian

Mary DeMars
Administrative Assistant, Evidence-Based Medicine Unit

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AAOS Evidence-Based Medicine Unit
www.orthoguidelines.org/auc or download the OrthoGuidelines app via Apple or Google Play stores
I. INTRODUCTION
OVERVIEW
The American Academy of Orthopaedic Surgeons (AAOS) has developed this Appropriate Use
Criteria (AUC) to determine appropriateness of various treatments for the Detection and
Nonoperative Management of Pediatric Developmental Dysplasia of the Hip in Infants up to Six
Months of Age (DDH). This AUC is not intended for use for children who have teratologic hip
abnormalities or hip abnormalities associated with neuromuscular, genetic, or acquired complex
musculoskeletal or developmental abnormalities. These AUCs are intended for use by
appropriately trained practitioners involved in the medical evaluation of typically developing
children less than 6 months of age. This would include pediatricians, family physicians,
qualified mid-level practitioners with appropriate physician oversight, radiologists who perform
diagnostic imaging of children, and orthopedic surgeons.
An “appropriate” healthcare service is one for which the expected health benefits exceed the
expected negative consequences by a sufficiently wide margin.2 Evidence-based information, in
conjunction with the clinical expertise of physicians from multiple medical specialties, was used
to develop the criteria in order to improve patient care and obtain the best outcomes while
considering the subtleties and distinctions necessary in making clinical decisions. To provide the
evidence foundation for this AUC, the AAOS Evidence-Based Medicine Unit provided the
writing panel and voting panel with the AAOS Clinical Practice Guideline on DDH, which can
be accessed via the following link: http://www.orthoguidelines.org/topic?id=1016.
The purpose of this AUC is to help determine the appropriateness of clinical practice guideline
recommendations for the heterogeneous patient population routinely seen in practice. The best
available scientific evidence is synthesized with collective expert opinion on topics where gold
standard randomized clinical trials are not available or are inadequately detailed for identifying
distinct patient types. When there is evidence corroborated by consensus that expected benefits
substantially outweigh potential risks, exclusive of cost, a procedure is determined to be
appropriate. The AAOS uses the RAND/UCLA Appropriateness Method (RAM)2 to assess the
appropriateness of a particular treatment. This process includes reviewing the results of the
evidence analysis, compiling a list of clinical vignettes, and having an expert panel comprised of
representatives from multiple medical specialties to determine the appropriateness of each of the
clinical indications for treatment as “Appropriate,” “May be Appropriate,” or “Rarely
Appropriate.” To access a more user-friendly version of the appropriate use criteria for this topic
online, please visit our AUC web-based application at www.orthoguidelines.org/auc or
download the OrthoGuidelines app from Google Play or Apple Store.
These criteria should not be construed as including all indications or excluding indications
reasonably directed to obtaining the same results. The criteria intend to address the most
common clinical scenarios facing all appropriately trained orthopaedic specialists, and other
qualified physicians managing patients with developmental dysplasia of the hip. The ultimate
judgment regarding any specific criteria should address all circumstances presented by the
patient and the needs and resources particular to the locality or institution. It is also important to
state that these criteria and are not meant to supersede clinician expertise and experience or
patient preference.
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AAOS Evidence-Based Medicine Unit
www.orthoguidelines.org/auc or download the OrthoGuidelines app via Apple or Google Play stores
INTERPRETING THE APPROPRIATENESS RATINGS
To prevent misuse of these criteria, it is extremely important that the user of this document
understands how to interpret the appropriateness ratings. The appropriateness rating scale ranges
from one to nine and there are three main range categories that determine how the median rating
is defined (i.e. 1-3 = “Rarely Appropriate”, 4-6 = “May Be Appropriate”, and 7-9 =
“Appropriate”). Before these AUCs are consulted, the user should read through and understand
all contents of this document.

BURDEN OF DISEASE
DDH is a spectrum of anatomic abnormalities of the femoral head and acetabulum of the hip
joint. There is inconsistent terminology used to describe these abnormalities and a lack of clarity
around which recognized abnormalities of the hip in the newborn and early infancy periods are
progressive and pathologic versus self-resolving and potentially within a range of normal
development. While clinical terms such as “click, clunk, dislocatable, subluxatable, reducible,
dysplastic, asymmetric thigh folds, and limited hip abduction” are common in papers related to
this topic, no clear or widely accepted clinical definitions exist by which to compare patient
populations to each other. In particular, the term “click” has been problematic as it has been
used in screening literature as a term describing a range of situations from a normal snapping
sensation to a surrogate for clinically detectable hip instability. Similarly, discussion of risk
factors for terms such as “foot deformities, talipes, family history, first born, female, and
intrauterine crowding/oligohydramnios” have been applied in a retrospective manner without
specificity and without consideration of other variables. Imaging criteria are similarly vague.
Included papers for this review demonstrated consistency of use of the Graf criteria for grading
severity of sonographic hip dysplasia, but consistent radiographic criteria for defining dysplasia
or dislocation were lacking.

Early detection and early management of DDH must take into account the early natural history
of physiologic hip development. The clinical practice guideline this AUC is based on included a
search for articles that defined the natural history of early clinical instability and early hip
dysplasia, as determined by either ultrasound or radiograph.

An estimation of the true incidence of the disorder is therefore uncertain. The reported incidence
ranges are as high as 1:100 newborns for clinically detectable hip instability, to 1-28:1000
newborns for clinically and/or radiographic hip dislocation that prompted an intervention I-1, I-2.
Recent large ultrasound screening studies place the incidence of ultrasound detectable
abnormalities leading to intervention at 5-7 percent of all newborns I-3, I-5. In the United States,
there were approximately 3,952,940 live births in 2012 I-6 suggesting a potential impact from
4,000 up to 276,700 newborn children/year in the United States.

The true prevalence of adult hip pathology attributable to DDH is unknown. It is widely
believed that DDH is a condition that can lead to impaired function and quality of life for
children and adults I-2, I-8, I-10 and that detection of this condition in early childhood may allow
interventions that can alter this. It is also believed that earlier treatment creates less potential
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AAOS Evidence-Based Medicine Unit
www.orthoguidelines.org/auc or download the OrthoGuidelines app via Apple or Google Play stores
harm to the child than later treatment with the aggregate risk of those harms being less than the
risk of impaired function and quality of life of the untreated condition I-4, I-11, I-18.

Current and evolving practice standards call for a musculoskeletal evaluation of all newborn
children and demand that practitioners be good stewards of health care resources in making such
assessments and decisions for management. These methods may involve both clinical and
imaging resources. In clinically normal hips imaging evaluation would be the only viable
method to assess for hip problems that could have a potential to evolve into a future pathologic
condition with adverse impact upon an individual’s quality of life. Population screening using
ultrasound has been practiced in Europe I-3, I-10, I-19, I-20 and with an uncertain role in North
America I-1. I-2, I-8.

NATURAL HISTORY
Published works on the topic of DDH have used inconsistent terminology to describe
abnormalities and have not clarified which recognized abnormalities of the hip in the newborn
and early infancy are progressive and pathologic versus self-resolving and potentially within a
range of normal development. The workgroup that built the clinical practice guideline on this
topic, attempted to identify as best as possible the natural history of clinically unstable or
ultrasound or radiographically abnormal hips detected in infancy with the natural duration of
self-correction. The long-term natural history of DDH appears to be related to the type and
severity of the hip abnormality. Mild dysplasia may never manifest clinically or become
apparent until adult life, whereas severe dysplasia can present clinically with functional
limitations during childhood. Interventions to alter the long- term natural history of DDH have
included early bracing and a progressive range of manipulative and surgical options with
advancing age of the child I-31 to I-43. The literature review included articles that specifically
included information related to the resolution of clinical instability or ultrasound and
radiographic hip dysplasia in untreated infants. All of the studies identified indicate that most
DDH discovered during the newborn period appear to represent hip laxity and immaturity.
Approximately 60 percent to 80 percent of abnormalities identified by physical examination and
more than 90 percent identified by ultrasound appear to resolve spontaneously in early infancy
raising significant questions about whether or not such hips should be treated with bracing and at
what age such treatment should be optimally applied.

ETIOLOGY
The etiology of DDH in typically developing children is unknown. Both genetic and
environmental influences appear to play a role in the development of this condition I-10, I-21.
Absence of a femoral head from within an acetabulum and alteration of proximal femoral
anatomy has been linked to progressive changes of the acetabulum over time I-22. Risk factors
for the development of progressive hip abnormality have been reported in observational series.

RISK FACTORS
The terminology used in defining risk factors for the presence of DDH is not precise in the
published literature. Hip physical examination findings associated with DDH have semantic
challenges, limited knowledge of normal ranges, and knowledge that the examination findings
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AAOS Evidence-Based Medicine Unit
www.orthoguidelines.org/auc or download the OrthoGuidelines app via Apple or Google Play stores